7/29/2026

speaker
Andrea
Conference Call Operator

Good morning and welcome to IONIS Second Quarter 2026 Financial Results Conference Call. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Wade Walke, Senior Vice President of Investor Relations, to lead off the call. Please go ahead.

speaker
Wade Walke
Senior Vice President, Investor Relations

Thank you, Andrea. Before we begin, I encourage everyone to go to the Investor section of the IONIS website To view the press release and related financial tables we will be discussing today, including a reconciliation of GAAP to non-GAAP financials. We believe non-GAAP financials results better represent the economics of our business and how we manage our business. We've also posted slides on our website that accompany today's call. With me this morning are Brett Monia, Chief Executive Officer, Kyle Genet, Chief Global Product Strategy Officer, Holly Kortasiewicz, Chief Development Officer, and Beth Hougen, Chief Financial Officer. Eugene Schneider, Chief Clinical Development Officer, and Eric Swayze, Executive Vice President of Research, will also join us for the Q&A portion of the call. I would like to draw your attention to slide three, which contains our forward-looking language statement. During this call, we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors contained in our SEC filings for additional detail. With that, I'll turn the call over to Brett.

speaker
Brett Monia
Chief Executive Officer

Thanks, Wade. Good morning, everyone, and thank you for joining us on today's call. Iona Center is the second half of 2026, well-positioned to achieve the strategic opportunities that lie ahead. We have the R&D engine, the pipeline, commercial capabilities, and financial discipline we need to execute on and achieve our goals. We are continuing to build momentum across our commercial medicines and, in parallel, We continue to strengthen and advance our wholly-owned pipeline to deliver our next wave of important medicines. Last month, we achieved a landmark milestone with the approval of Tringolza as the first and only FDA-approved medicine to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia, or SHTG. Although still early days, we are highly encouraged. With our launch momentum to date, in fact, we began receiving prescriptions for Tringolza on the day of approval. We are also pleased that both the 50mg and 80mg doses were in the channel within one week. Based on a strong profile and the enthusiasm we are seeing in prescribing, we are confident that Tringolza is well-positioned to help a large population of patients in need and become the first Ionis-owned multi-billion-dollar medicine. Donzara for hereditary angioedema also continues to gain momentum. We expect Donzara to continue driving growth as it and more established in the HAE prophylactic treatment landscape. We also continue to advance our leadership in the development of breakthrough treatments for a wide range of neurological diseases. We remain on track for the anticipated launch of Zilgen-Nersen coming up soon, which is positioned to be the first disease-modifying treatment for Alexander disease and the first independent launch from our neurological disease pipeline. Falling closely behind Zilgen-Nersen is Zobudden-Nersen, our medicine for Angelman syndrome, which completed an enrollment in the phase three reveal study last month, keeping it on track for data next year. Earlier this month, we also announced the initiation of clinical development for ion 337 in Dravet syndrome, expanding our clinical stage neurology pipeline, which now includes eight medicines that are wholly owned. Complementing our wholly owned pipeline is our partnered pipeline, which includes medicines targeting both rare and highly prevalent diseases providing significant additional value for ionis. This includes Bepiravircin, our medicine for chronic hepatitis B. With the PDUFA target action date of October 26 and additional global filings under review, Bepiravircin is on track for a global launch this year, positioning it to be a first in-class medicine for the millions of people around the world living with this disease. Data from the Phase III pellicarsin LpA horizon study in patients with elevated LpA in cardiovascular disease is also a key catalyst coming up in the second half of this year. We were disappointed with the outcome of the CardioTransform Phase III study for eplontersin in ATTR cardiomyopathy that we reported earlier this month. Although eplontersin demonstrated substantial and durable reductions in TTR, nominally significant results in the monotherapy subgroup and favorable safety. It did not meet the primary efficacy endpoint in the overall population. We and AstraZeneca continue to analyze the data and will present the results at ESC in August. Our strong commercial execution, continued pipeline progress, and our strong second quarter financial performance underscore the many opportunities we have to continue building substantial value. We remain on track to deliver on our 2026 financial guidance and achieve our goal of cash flow break even in 2028. With that, I'll now turn the call over to Kyle, who will speak to the commercial execution of Tringolza and Donzera and launch preparations for Zilgen Ersin. Holly will then discuss how we are advancing our pipeline, highlighting several important catalysts ahead, and Beth will review our financial results and outlook. And with that, I'll turn it over to Kyle.

Disclaimer

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